Fluoroscopy operator protection device

ABSTRACT

A radiation protection device attaches to the C-arm of a fluoroscope and shields and collimates the X-ray beam between the X-ray source and the patient and between the patient and the image intensifier. One embodiment has a radiation shield of X-ray opaque material that surrounds the C-arm of the fluoroscopy system, the X-ray source and the image intensifier. A padded slot fits around the patient&#39;s body. Another embodiment has conical or cylindrical radiation shields that extend between the X-ray source and the patient and between the patient and the image intensifier. The radiation shields have length adjustments and padded ends to fit the device to the patient. The radiation protection device may be motorized to advance and withdraw the radiation shields. A blanket-like radiation shield covers the patient in the area surrounding where the X-ray beam enters the body.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/344,426, filed Jan. 5, 2012, which is a continuation of U.S. patentapplication Ser. No. 12/313,782, filed Nov. 21, 2008, which is acontinuation-in-part of PCT/US2007/023892, filed Nov. 7, 2007, whichclaims the benefit of Provisional Application No. 60/858,058, filed onNov. 11, 2006, and Provisional Application No. 60/923,481, filed on Apr.13, 2007, the full disclosures of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention.

The present invention relates to radiation protection devices to protectfluoroscopy operators and other medical personnel from radiationexposure during fluoroscopic imaging procedures.

Fluoroscopy, a real-time X-ray imaging technique, has long beenimportant as a medical diagnostic tool, particularly in disciplineswhere still X-rays do not provide sufficient diagnostic information ofthe movement and function of living, moving organs. Fluoroscopy iswidely used in cardiology, electrophysiology, gastroenterology andorthopedics. With the recent growth in catheter-based interventionalcardiology and radiology procedures, there has been a tremendousincrease in the use of fluoroscopy. Many life saving interventionalprocedures would not be possible without the use of fluoroscopy.However, fluoroscopic imaging exposes the patient and attendant medicalpersonnel to potentially harmful X-ray radiation. For the patient, someexposure to X-rays is necessary to produce the fluoroscopic images andthe exposure is usually brief and infrequent. The benefit to the patientis sufficient to outweigh the potentially harmful effects of the X-rayradiation. However, medical personnel involved in fluoroscopic imagingare exposed to significant doses of X-ray radiation on a daily basis.This is particularly true for interventional cardiologists andradiologists who must work in close proximity to the patient who isundergoing fluoroscopic imaging and for orthopedists manipulating ajoint while observing it under fluoroscopy.

X-ray exposure to medical personnel comes from two sources, directexposure to the X-ray beam and scattered X-rays. Direct exposure occurswhen the operator's hands or other body parts are placed in the X-raybeam while the fluoroscope is operating. X-ray scattering occurs whenX-rays strike electrons in the patient's tissue and are deflected backand to the sides at angles that are not parallel to the incident beam.While scattered X-rays are much lower intensity than the direct X-raybeam, it is much more likely for the operator to be exposed to scatteredX-rays and the damaging effects are cumulative from months and years ofexposure.

Most states require that all medical personnel who work in the roomduring fluoroscopy wear protective equipment, typically a radiationresistant apron or the like providing protection equivalent to 0.25-0.5mm of lead, depending on state regulations and the intensity of theX-ray source utilized. Depending on the thickness used, lead apronsabsorb 90-99 percent of X-ray radiation striking the apron. However,they only protect the areas of the body that are covered and it isrecommended that personnel who work frequently and in close proximity tothe fluoroscope also wear additional protection, such as thyroidprotectors, lead filled glasses and face shields. Exposed areas of thebody are still susceptible to X-ray exposure.

Though necessary for radiation protection, the lead aprons are heavy anduncomfortable, resulting in fatigue and injuries. Back, knee and ankleinjuries are common among personnel who frequently work in thefluoroscopy laboratory with a lead apron on. X-ray exposure, fatigue andinjuries would all be expected to increase for operators involved inlong, complex interventional procedures requiring fluoroscopic imaging.

Due to the incomplete radiation protection provided by lead aprons andleaded glasses and the increased likelihood of fatigue and injuries, itwould be desirable to provide a radiation protection device thatprovides more complete protection and that reduces or eliminates thenecessity for using heavy radiation protection garments. Such a devicewould ideally protect the fluoroscope operator and all nearby personnelfrom direct exposure to the X-ray beam and from scattered X-rays. Thedevice should not interfere with the performance of the fluoroscopy orany diagnostic or therapeutic procedures performed during fluoroscopy.Preferably, the device would be free of other inconveniences to theoperator or the patient. A truly effective radiation protection devicecould reduce the overall cost of radiation protection by eliminating theneed for lead aprons and other protective gear and could even simplifythe construction of the fluoroscopy suite in the hospital by decreasingthe amount of radiation shielding necessary.

BRIEF SUMMARY OF THE INVENTION

In keeping with the foregoing discussion, the present invention providesa radiation protection device with one or more radiation shields thatattach to the C-arm of the fluoroscopy system and shields and collimatesthe X-ray beam between the X-ray source and the patient and between thepatient and the image intensifier. This will protect the operator frominadvertently being exposed to the direct X-ray beam and will eliminatea significant percentage of the scattered X-rays. To eliminate theremainder of the scattered X-rays that emanate from the patient, theradiation protection device may also include a blanket-like radiationshield that covers the patient in the area surrounding where the X-raybeam enters the body. Optionally, the blanket-like radiation shield maybe connected to the radiation shield(s) on the C-arm.

In one embodiment, the radiation protection device has a radiationshield of X-ray opaque material that surrounds the C-arm of thefluoroscopy system, the X-ray source and the image intensifier. A slotor opening is provided to fit the radiation shield around the patient'sbody. A soft, flexible material surrounds the opening to comfortably fitthe radiation shield to the contours of the patient's body and toaccommodate some motion of the C-arm relative to the patient.

In another embodiment, the radiation protection device has a firstconical or cylindrical radiation shield that extends from the X-raysource to the patient or to the procedure table and a second conical orcylindrical radiation shield that extends from the patient to the imageintensifier. The first radiation shield and the second radiation shieldhave length or height adjustments to fit the device to the patient andto accommodate motion of the C-arm relative to the patient. A soft,flexible material surrounds the openings of the first radiation shieldand the second radiation shield to comfortably fit them to the contoursof the patient's body. Optionally, the radiation protection device haselectric motors or the like for withdrawing and advancing the firstradiation shield and the second radiation shield from contact with thepatient so that the C-arm can be freely moved and repositioned relativeto the patient. Optionally, the second radiation shield may have one ormore hand ports to allow the operator to work on the area of the patientunder the second radiation shield without withdrawing it from contactwith the patient. Each embodiment of the radiation protection device mayalso include a blanket-like radiation shield that covers the patient inthe area surrounding where the X-ray beam enters the body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a prior art C-arm fluoroscopy system.

FIG. 2 illustrates one embodiment of the radiation protection devicemounted on the C-arm of the fluoroscopy system.

FIG. 3 illustrates a variation of the radiation protection device ofFIG. 2.

FIG. 4 illustrates an embodiment of the radiation protection device witha first radiation shield and a second radiation shield mounted on theC-arm of the fluoroscopy system.

FIG. 5 illustrates a radiation shield with a hand port.

FIG. 6 illustrates a radiation shield with two hand ports.

FIG. 7 illustrates an embodiment of the radiation protection device withmotors for extending and retracting the first radiation shield and thesecond radiation shield.

FIG. 8 illustrates a blanket-like radiation shield that covers thepatient except the area that is being imaged.

FIG. 9 illustrates a radiation shield elevated slightly above andsurrounding the patient.

FIG. 10 illustrates a radiation shield suspended from the X-ray sourceof the fluoroscopy system.

FIG. 11 illustrates a fluoroscope C-arm with a radiation protectiondevice having counterweights connected to the first radiation shield andthe second radiation shield.

FIG. 12 illustrates a fluoroscope C-arm with a radiation protectiondevice wherein the first radiation shield and the second radiationshield act as counterweights to each other via a cable and pulleyconnection system.

FIG. 13 illustrates a fluoroscope C-arm with a radiation protectiondevice wherein the first radiation shield and the second radiationshield act as counterweights to each other via a pneumatic or hydraulicconnection system.

FIG. 14 illustrates a fluoroscope C-arm with a radiation protectiondevice wherein the first radiation shield and the second radiationshield act as counterweights to each other via a pneumatic or hydraulicconnection system.

FIG. 15 illustrates an articulated conical radiation shield shown in afully extended position.

FIG. 16 illustrates the articulated conical radiation shield of FIG. 15shown in an angled position.

FIG. 17 illustrates an articulated cylindrical radiation shield shown ina fully extended position.

FIG. 18 illustrates the articulated cylindrical radiation shield of FIG.17 shown in an angled position.

FIG. 19 illustrates an articulated conical radiation shield withtelescoping dome-shaped shield elements.

FIG. 20 illustrates an articulated conical radiation shield with anactuation system using linear actuators for extending, retracting andangulating the radiation shield, shown in an angled position.

FIG. 21 illustrates a fluoroscope C-arm with a radiation protectiondevice with conical radiation shields shown in a retracted position.

FIG. 22 illustrates a fluoroscope C-arm with the radiation protectiondevice of FIG. 21 with conical radiation shields shown in an extendedposition.

FIG. 23 illustrates a fluoroscope C-arm with a radiation protectiondevice with articulated conical radiation shields shown in a retractedposition.

FIG. 24 illustrates a fluoroscope C-arm with the radiation protectiondevice of FIG. 23 with articulated conical radiation shields shown in anextended position.

FIG. 25 is an anterior view of a patient wearing a radiation protectiongarment for use with the radiation protection device of the presentinvention.

FIG. 26 is a posterior view of the patient wearing a radiationprotection garment of FIG. 25.

FIG. 27 is an anterior view of a patient wearing a radiation protectiongarment for use with the radiation protection device of the presentinvention.

FIG. 28 is a posterior view of the patient wearing a radiationprotection garment of FIG. 27.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a prior art C-arm fluoroscopy system 100. Thefluoroscope 100 includes an X-ray source 102 and an image intensifier104 mounted on opposite ends of a C-arm 106. The C-arm 106 may bemounted on a mobile base with wheels, as shown, or it may be mounted viaa support arm to the floor or the ceiling of the fluoroscopy suite. Inuse, the X-ray source 102 and the image intensifier 104 are placed onopposite sides of the portion of the patient's body to be imaged. TheX-ray source 102 directs an X-ray beam through the patient's body towardthe image intensifier 104, which captures the X-ray image and displaysit on a monitor 108 in real time. Often, the X-ray source 102 ispositioned below the patient and the image intensifier 104 is positionedabove as shown, however for some applications these positions may bereversed or the C-arm 106 may be positioned horizontally or at anoblique angle. The system may also include electronic memory for storingand replaying fluoro images and a cine camera for capturing fluoroimages on film. For catheterization laboratory use, the C-arm 106 willbe mounted beside or at the head end of a procedure table. The C-arm 106can be moved and rotated to position the X-ray source 102 and the imageintensifier 104 for the best images of the target anatomy. Often, theX-ray source 102 is positioned below the patient and the imageintensifier 104 is positioned above as shown, however for someapplications these positions may be reversed or the C-arm 106 may bepositioned horizontally or at an oblique angle.

FIG. 2 illustrates one embodiment of the radiation protection device 110mounted on the C-arm 106 of the fluoroscopy system 100. The radiationprotection device 110 includes a radiation shield 112 of X-ray opaquematerial that surrounds the C-arm 106 of the fluoroscopy system 100, theX-ray source 102 and the image intensifier 104. The radiation shield 112has a first approximately planar side wall 114 and a secondapproximately planar side wall 116 joined together by a peripheral wall118. A slot or opening 120 through the first and second side walls 114,116 and the peripheral wall 118 is provided to fit the radiation shield112 around the patient's body and, optionally, the procedure table, asappropriate for the intended use. The back side of the peripheral wall118 will have an opening or extended slot 126 for the support arm 128that holds the C-arm 106. A pad 122 of soft, flexible material surroundsthe opening 120 to comfortably fit the radiation shield to the contoursof the patient's body and to accommodate some motion of the C-arm 106relative to the patient. Optionally, the opening 120 can be covered witha material that is transparent to X-rays. The pad 122 around the opening120 may be an inflatable or foam-filled rim of lead-filled rubber orother soft, conformable structure. The radiation protection device 110may be joined directly to the C-arm 106 with fasteners and/or adhesivesor it may be an independent structure that can be placed on and removedfrom the C-arm 106, for example with zippers, magnets, snaps, straps,hook-and-loop fasteners, etc.

The radiation shield(s) in this and other embodiments may be made withlead shielding, a composite material or other X-ray opaque material.Preferably, the radiation shielding material will provide protectionequivalent to 0.5 mm of lead or greater so that additional radiationprotection will not be needed. For example, U.S. Pat. No. 4,795,654describes a composite X-ray opaque material with a triple layerstructure. The first layer can be built from uranium, lead and goldamong others. The second layer may be made of tin, and indium amongothers and the third layer made of zinc, copper, nickel and chromiumamong others. Alternatively, a polymer shielding material filled withX-ray opaque materials may have weight, manufacturing and structuraladvantages over a metallic shielding material. Optionally, the shieldingmaterial may be flexible, such as lead filled rubber or plastic, and itmay be optically transparent, such as lead filled glass or a transparentX-ray opaque plastic. For example, flexible and rigid polymeric X-rayopaque materials sold under the tradename DEMRON are available fromRadiation Shielding Technologies, Coral Gables, Fla. and described inU.S. Pat. Nos. 6,841,791, 6,828,578, 6,459,091, 6,281,515 and 7,196,023.

FIG. 3 illustrates a variation of the radiation protection device 110 ofFIG. 2 in which the radiation shield 112 has a C-arm attached portion126 and a patient-stationary portion 128. An overlapping, sliding joint130 between the C-arm attached portion 126 and the patient-stationaryportion 128 allows a greater range of motion of the C-arm 106 relativeto the patient. Optionally, a flap 124 of X-ray opaque material,preferably a flexible material, may be provided to cover a portion ofthe opening 120 after it has been passed around a body part. The flap124 may be removably attached, for example using magnets, snaps orhook-and-loop fasteners.

In an alternate embodiment of the radiation protection device 110 ofFIG. 2, the radiation shield 112 may be independently supported, so thatit is held stationary relative to the patient, allowing the C-arm 106 tomove independently within the radiation shield 112.

FIG. 4 illustrates an embodiment of the radiation protection device 130with a first radiation shield 132 and a second radiation shield 134mounted on the C-arm 106 of the fluoroscopy system 100. The firstradiation shield 132 is approximately conical or cylindrical in shapeand extends from the X-ray source 102 to the patient, or to theprocedure table 140 as appropriate for the body part being imaged. Thesecond radiation shield 134 is also approximately conical or cylindricalin shape and extends from the image intensifier 104 to the patient. Theradiation shields 132, 134 are typically open on the ends closest to thepatient, but, optionally, the openings can be covered with a materialthat is transparent to X-rays.

The first radiation shield 132 and the second radiation shield 134 havelength or height adjustments 136, 138 to fit the device to the patientand to accommodate motion of the C-arm 106 relative to the patient. Thelength or height adjustments 136, 138 may be configured as overlappingtelescopic joints, expandable bellows joints or the like. A pad 142, 144of soft, flexible material surrounds the openings of the first radiationshield 132 and the second radiation shield 134 to comfortably fit themto the contours of the patient's body. The pads 142, 144 around theopenings may be an inflatable or foam-filled rim of lead-filled rubberor other soft, conformable structure. The conformable pads 142, 144 maybe shaped as bellows of flexible X-ray opaque material. Alternatively orin addition, the conformable pads 142, 144 may be configured asinflatable tubes or bellows filled with an X-ray opaque liquid. Thelength or height adjustments 136, 138 and the conformable pads 142, 144allow for a significant degree of repositioning of the C-arm 106relative to the patient without having to readjust the radiation shields132, 134. Optionally, the length or height adjustments 136, 138 may bespring loaded with a light spring force to keep the radiation shields132, 134 in contact with the patient when the C-arm 106 is adjustedwithout causing discomfort to the patient. For major repositioning ofthe C-arm 106, the radiation shields 132, 134 will preferably bewithdrawn from contacting the patient in order to allow free motion ofthe C-arm 106.

Optionally, the second radiation shield 134 may have one or more handports to allow the operator to work on the area of the patient under thesecond radiation shield 134 without withdrawing it from contact with thepatient. FIG. 5 illustrates a radiation shield 134 with a single handport 150 large enough for both of the operator's hands and/or one ormore instruments to fit through. The hand port 150 is preferably fittedwith a closure 156 of radiation shielding material to prevent X-raysfrom escaping through the hand port 150. In one preferred embodiment,the closure comprises a plurality of overlapping flaps of flexibleradiation shielding material that will allow a hand or instrument topass through and will seal around the hand or instrument.

FIG. 6 illustrates a radiation shield with two hand ports 152, 154. Eachof the hand ports 152, 154 is preferably fitted with a closure 156 ofradiation shielding material to prevent X-rays from escaping through thehand ports 152, 154.

Preferably, when a hand port is included in the radiation protectiondevice 130, at least a portion of the radiation shield 134 will be madeof transparent radiation shielding material so that the operator can seethe area under the radiation shield 134. If the operator needs to havethe hands inside of the radiation shield 134 while the fluoroscope 100is operating, it is highly recommended that radiation shielding glovesbe worn. In an alternate embodiment, a pair of radiation shieldinggloves could be incorporated into the hand ports 152, 154.

Optionally, the radiation protection device 130 may be motorized forextending and retracting the first radiation shield 132 and the secondradiation shield 134 from contact with the patient so that the C-arm canbe freely moved and repositioned relative to the patient. FIG. 7illustrates an embodiment of the radiation protection device 130 withmotors 156, 158 for extending and retracting the first radiation shield132 and the second radiation shield 134. The motors 156, 158 may beelectric motors with a rack and pinion mechanism, a scissors mechanism,or other mechanism 133, 135 for translating the rotary motion of themotor into linear motion of the radiation shields 132, 134. Optionally,the operating mechanism may be spring loaded with a light spring forceto keep the radiation shields 132, 134 in contact with the patient whenthe C-arm 106 is adjusted without causing discomfort to the patient. Formajor repositioning of the C-arm 106, the radiation shields 132, 134will preferably be withdrawn from contacting the patient in order toallow free motion of the C-arm 106. Alternatively, pneumatic orhydraulic actuators may be used in place of the electric motors.

Preferably, the radiation protection device 130 will also includesensors 160, 162, such as proximity sensors, optical sensors, contactsensors, etc., that will stop the telescopic extension of the radiationshields 132, 134 when they are in the right contact with the patient.One option would be to have the conforming pads 142, 144 around theopenings of the radiation shields 132, 134 mechanized to operate in acoordinated sequence with the extension and retraction of the radiationshields 132, 134. In one example, the conforming pads 142, 144 could beinflatable. The radiation shields 132, 134 would extend telescopicallywith the pads 142, 144 deflated until the sensors 160, 162 detect closeproximity or initial contact with the patient's body, then the radiationshields 132, 134 would stop extending and the pads 142, 144 wouldinflate to close any gap left between the radiation shields 132, 134 andthe patient.

Alternately or in addition, force sensors connected with the motors 156,158 could be used to sense when the radiation shields 132, 134 are incontact with the patient.

An interlock switch could be included to prevent the fluoroscope 100from operating unless the sensors 160, 162 confirm that the radiationshields 132, 134 are in contact with the patient's body. In addition,one or more X-ray detectors could be positioned on or near the radiationprotection device 130 outside of the radiation shields 132, 134 todetect X-ray leakage and connected to an interlock switch that shutsdown the X-ray source if stray X-ray radiation is detected.

Each embodiment of the radiation protection device may also include ablanket-like radiation shield that covers the patient in the areasurrounding where the X-ray beam enters the body. Optionally, theblanket-like radiation shield may be connected to the radiationshield(s) on the C-arm.

FIG. 8 illustrates a blanket-like radiation shield 170 that covers thepatient except the area that is being imaged. The blanket-like radiationshield 170 is preferably made of a flexible X-ray opaque material thatcovers most of the patient, except a fenestrated area 172 over theportion of the patient that is to be imaged. For catheter procedures, asecond fenestration may be positioned over the vascular access site, forexample the femoral or brachial artery or the jugular vein. Preferably,the radiation shielding material will provide protection equivalent to0.5 mm of lead or greater. Because scattered X-rays are only partiallyattenuated in the body, this level of protection will preferably extendat least to areas of the body within a meter of where the X-ray beamenters the patient's body. Optionally, the blanket-like radiation shield170 may have a removable cover for patient comfort and for ease insanitizing the patient-contact portions of the device. The removablecover may be washable and reusable or it may be a single-use steriledisposable cover.

FIG. 9 illustrates a radiation shield 180 elevated slightly above andsurrounding the patient, except a fenestrated area 182 over the portionof the patient that is to be imaged. If a rigid radiation shieldingmaterial is used, the radiation shield 180 may be self-supporting.Otherwise, a flexible radiation shielding material may be supported on aframe over the patient.

In addition, another radiation shield may extend under the patient, withanother fenestration under the portion of the patient to be imaged.Optionally, this radiation shield may be an extension of theblanket-like radiation shield 170, 180 that is over the patient.Alternatively, the procedure table may be made partially of radiationshielding material with an X-ray transparent portion beneath the portionof the patient to be imaged, however this option potential limits theusability of the procedure table for different types of procedures.Optionally, the blanket-like radiation shield 170, 180 may fasten to oneor both of the radiation shields of the radiation protection device.

FIG. 10 illustrates a radiation shield 190 suspended from the X-raysource 102 of the fluoroscopy system 100. This is a curtain-likeradiation shield 190 that hangs down between the X-ray source 102 andthe floor to stop scattered X-ray radiation. This radiation shield 190may be used separately or in combination with one of the embodiments ofthe radiation protection device described herein.

Alternatively or in addition to the blanket-like radiation shield, theradiation protection device may include a garment-like radiation shieldthat covers the patient in the area surrounding where the X-ray beamenters the body. FIG. 25 is an anterior view and FIG. 26 is a posteriorview of a patient wearing a radiation protection garment 410 in the formof a broad belt made of X-ray opaque material. The belt-shaped radiationprotection garment 410 substantially covers the patient's abdomen and aportion of the thorax. There is a fenestration 412 through the anteriorportion of the belt-shaped radiation protection garment 410 in the areaof the patient's anatomy to be imaged, in this example, the patient'sabdomen. Likewise, there is a fenestration 414 through the posteriorportion of the belt-shaped radiation protection garment 410, generallyopposite to the fenestration 412 in the front. The belt-shaped radiationprotection garment 410 is preferably made from a flexible X-ray opaquematerial. Preferably, a simple-to-operate fastener 416, such as ahook-and-loop fastener, a zipper or a magnetic fastener, is provided onthe belt-shaped radiation protection garment 410 for putting the garmenton and taking it off of the patient. The fact that the radiationprotection garment 410 surrounds the portion of the patient to beexposed to the X-ray beam effectively blocks any stray radiation beingemitted from the flanks of the patient. Optionally, the radiationprotection garment 410 may fasten to one or both of the radiationshields of the radiation protection device.

FIG. 27 is an anterior view and FIG. 28 is a posterior view of a patientwearing a radiation protection garment 420 in the form of a vest made ofX-ray opaque material. The vest-shaped radiation protection garment 420extends from the patient's neck and shoulders to the patient's waist andhips or lower. There is a fenestration 422 through the anterior portionof the vest-shaped radiation protection garment 420 in the area of thepatient's anatomy to be imaged, in this example, the patient's thorax.Likewise, there is a fenestration 424 through the posterior portion ofthe vest-shaped radiation protection garment 420, generally opposite tothe fenestration 422 in the front. The vest-shaped radiation protectiongarment 420 is preferably made from a flexible X-ray opaque material.Preferably, a simple-to-operate fastener 426, such as a hook-and-loopfastener, a zipper or a magnetic fastener, is provided on thevest-shaped radiation protection garment 420 for putting the garment onand taking it off of the patient. The fact that the radiation protectiongarment 420 surrounds the portion of the patient to be exposed to theX-ray beam effectively blocks any stray radiation being emitted from theflanks of the patient. Optionally, the radiation protection garment 420may fasten to one or both of the radiation shields of the radiationprotection device.

Alternatively or in addition, the radiation protection device may beused for protection from other types of radiation, for example gammarays, that are used in medical or industrial imaging or other diagnosticor therapeutic medical procedures.

FIG. 11 illustrates a fluoroscope C-arm 106 with a radiation protectiondevice 130 having a first radiation shield 132 connected to the X-raysource 102 and a second radiation shield 134 connected to the imageintensifier 104. The first radiation shield 132 is configured with afirst stationary shield 204 adjacent to the X-ray source 102 and a firstmoving shield 206 that moves telescopically with respect to the firststationary shield 204. The first stationary shield 204 will generally becylindrical in shape, and the first moving shield 206 will generally becylindrical or conical in shape. A first flexible and/or inflatableconforming pad 142 is mounted around the opening on the inner end of thefirst moving shield 206. A first inner pulley 208 is mounted adjacent tothe inner edge of the first stationary shield 204 and a first outerpulley 210 is mounted adjacent to the outer edge of the first stationaryshield 204. The first inner pulley 208 and the first outer pulley 210may be mounted directly on the first stationary shield 204 or they maybe mounted on a structure that is fixed with respect to the firststationary shield 204. (Note that the designations of “outer” and“inner” are given with respect to the center of the C-arm 106 where thepatient is positioned, as shown in the illustration.) A continuous firstloop of cable 212, or the like, loops around the first inner pulley 208and the first outer pulley 210. The first loop of cable 212 is attachedadjacent to the inner edge of the first moving shield 206 at a firstattachment point 214. The first loop of cable 212 is also attached to afirst counterweight 200 at a point approximately 180 degrees apart fromthe first attachment point 214 on the first loop of cable 212. As thefirst moving shield 206 moves inward, the first counterweight 200 movesoutward, and vise versa. The first counterweight 200 is sized tocounteract all or a portion of the weight of the first moving shield206, which reduces the force required to move the first moving shield206. Movement of the first moving shield 206 can be active, e.g. with amotor or another actuator mechanism, or it may be passive, e.g. with alight spring that urges the first moving shield 206 inward toward theextended position (upward in the illustration).

Similarly, the second radiation shield 134 is configured with a secondstationary shield 224 adjacent to the image intensifier 104 and a secondmoving shield 226 that moves telescopically with respect to the secondstationary shield 224. The second stationary shield 224 will generallybe cylindrical in shape, and the second moving shield 226 will generallybe cylindrical or conical in shape. A second flexible and/or inflatableconforming pad 144 is mounted around the opening on the inner end of thesecond moving shield 226. A second inner pulley 228 is mounted adjacentto the inner edge of the second stationary shield 224 and a second outerpulley 230 is mounted adjacent to the inner edge of the secondstationary shield 224. The second inner pulley 228 and the second outerpulley 230 may be mounted directly on the second stationary shield 224or they may be mounted on a structure that is fixed with respect to thesecond stationary shield 224. A continuous second loop of cable 232, orthe like, loops around the second inner pulley 228 and the second outerpulley 230. The second loop of cable 232 is attached adjacent to theinner edge of the second moving shield 226 at a second attachment point234. The second loop of cable 232 is also attached to a secondcounterweight 202 at a point approximately 180 degrees apart from thesecond attachment point 234 on the second loop of cable 232. As thesecond moving shield 226 moves inward, the second counterweight 202moves outward, and vise versa. The second counterweight 202 is sized tocounteract all or a portion of the weight of the second moving shield206, which reduces the force required to move the second moving shield206. Movement of the second moving shield 206 can be active, e.g. with amotor or another actuator mechanism, or it may be passive, e.g. with alight spring that urges the second moving shield 206 inward toward theextended position (downward in the illustration).

The configuration of the counterweight system automatically compensatesfor changes in the angle of the fluoroscope C-arm 106 because theeffective weight of the first and second moving shields 206, 226, aswell as the first and second counterweights 200, 202, will beproportional to the sine of the angle .alpha. between the imaging axis240 of the fluoroscope C-arm 106 and a horizontal axis 242. Acounterweighting system depending on springs, or the like, to counteractthe weight of the first and second moving shields 206, 226 would notautomatically compensate for changes in the angle of the fluoroscopeC-arm 106 in the same way. The continuous loop configuration of thefirst and second cables 212, 232 assures that the cables 212, 232 alwaysoperate in tension no matter what angle the fluoroscope C-arm 106 ispositioned at, even when the C-arm 106 is inverted. The pulleys andcables of the counterweight system may also be utilized as part of anactuator mechanism for extending and retracting the first and secondradiation shields 132 134.

FIG. 11 also illustrates another optional feature of the radiationprotection device 130. The first radiation shield 132 is configured suchthat the first moving shield 206 is larger in diameter than the firststationary shield 204 and moves telescopically on the outside of thefirst stationary shield 204. Conversely, the second radiation shield 134is configured such that the second moving shield 226 is smaller indiameter than the second stationary shield 224 and moves telescopicallyon the inside of the second stationary shield 224. This arrangementassures that X-rays originating from the X-ray source 102 cannot escapethe first radiation shield 132 through the gap between the first movingshield 206 and the first stationary shield 204. Similarly, X-raysentering the inner end of the second radiation shield 134 is cannotescape through the gap between the second moving shield 226 and thesecond stationary shield 224. Alternatively, the radiation protectiondevice 130 may utilize special joints, such as the overlapping flangejoints described in connection with FIGS. 15-18, to contain the X-raybeam.

Alternatively, the radiation protection device 130 can be configured sothat it is self-counterbalancing, that is, the first radiation shield132 and the second radiation shield 134 counterbalance each otherwithout the addition of separate counterweights, as in the previousexample in FIG. 11. One advantage of this is that it reduces the forceneeded to extend and retract the first and second radiation shields 132,134 without the additional weight of separate counterweights. It alsoprovides a simple means to extend and retract the first and secondradiation shields 132, 134 in unison.

FIG. 12 illustrates a fluoroscope C-arm 106 with a radiation protectiondevice 130 wherein the first radiation shield 132 and the secondradiation shield 134 act as counterweights to each other via a cable andpulley connection system. The first and second radiation shields 132,134 are configured similarly to the previous example in FIG. 11. A firstpulley 244 is mounted adjacent to the inner edge of the first stationaryshield 204. The first pulley 244 may be mounted directly on the firststationary shield 204 or it may be mounted on a structure that is fixedwith respect to the first stationary shield 204. A second pulley 246 ismounted adjacent to the inner edge of the second stationary shield 224.The second pulley 246 may be mounted directly on the second stationaryshield 224 or it may be mounted on a structure that is fixed withrespect to the second stationary shield 224. A continuous loop of cable248 loops around the first pulley 244 and the second pulley 246, passingaround the C-arm 106 from the first radiation shield 132 to the secondradiation shield 134. A series of additional pulleys 254 support thecontinuous loop of cable 248 as it passes around the C-arm 106. Thenumber and configuration of additional pulleys 254 needed depends on thegeometry of the C-arm 106. Alternatively, push-pull cables with alow-friction coaxial sheath may be used to connect the continuous loopof cable 248 as it passes around the C-arm 106. The continuous loop ofcable 248 is attached adjacent to the inner edge of the first movingshield 206 at a first attachment point 250 and is also attached adjacentto the inner edge of the second moving shield 226 at a second attachmentpoint 252, which is on the opposite side of the first pulley 244 and thesecond pulley 246 from the first attachment point 250. Thisconfiguration assures that the first radiation shield 132 and the secondradiation shield 134 will extend and retract in unison, with the weightof the first moving shield 206 and the weight of the second movingshield 226 counterbalancing each other. The continuous loopconfiguration of the cable 248 assures that the cables 212, 232 alwaysoperate in tension no matter what angle the fluoroscope C-arm 106 ispositioned at, even when the C-arm 106 is inverted. Movement of thefirst and second moving shields 206, 226 can be active, e.g. with amotor or another actuator mechanism, or it may be passive, e.g. with alight spring that urges the first and second moving shields 206, 226inward toward the extended position. The pulleys and cables of theself-counterweighting system may also be utilized as part of an actuatormechanism for extending and retracting the first and second radiationshields 132 134. As with the example in FIG. 11, the configuration ofthe self-counterweighting system automatically compensates for changesin the angle of the fluoroscope C-arm 106 because the effective weightof the first and second moving shields 206, 226 will be proportional tothe sine of the angle .alpha. between the imaging axis 240 of thefluoroscope C-arm 106 and a horizontal axis 242.

A self-counterbalancing radiation protection device 130 can also beaccomplished using a pneumatic or hydraulic connection system. FIG. 13illustrates a fluoroscope C-arm 106 with a radiation protection device130 wherein the first radiation shield and the second radiation shieldact as counterweights to each other via such a pneumatic or hydraulicconnection system. The first and second radiation shields 132, 134 areconfigured similarly to the example in FIG. 12. A first pneumatic orhydraulic cylinder 260 is connected between the first stationary shield204 and the first moving shield 206. A second pneumatic or hydrauliccylinder 262 is connected between the second stationary shield 224 andthe second moving shield 226. Connection points can be any convenientpoints on the stationary shields 204, 224 and moving shields 206, 226that will allow the desired range of motion. For example, pneumatic orhydraulic cylinders 260, 262 may be connected at the outer ends of thestationary shields 204, 224 and the outer ends of the moving shields206, 226, as shown in FIG. 13. A connection tube 264 makes a fluidconnection between the rod end 266 of the first pneumatic or hydrauliccylinder 260 and the cylinder head end 268 of the second pneumatic orhydraulic cylinder 262, or vise versa. The cylinder head end 274 of thefirst pneumatic or hydraulic cylinder 260 has a first vent 276 and therod end 270 of the second pneumatic or hydraulic cylinder 262 has asecond vent 272. Connecting between opposite ends of the first andsecond pneumatic or hydraulic cylinders 260, 262 assures that the firstand second radiation shields 132, 134 will extend and retract in unison,with the weight of the first moving shield 206 and the weight of thesecond moving shield 226 counterbalancing each other. Naturally, atleast the first pneumatic or hydraulic cylinder 260 must be adouble-acting cylinder, or the like, that can be pressurized from therod end 266 of the cylinder. The first pneumatic or hydraulic cylinder260 may be slightly larger in diameter than the second pneumatic orhydraulic cylinder 262 to compensate for the area of the rod 278 so thatthe first moving shield 206 and the second moving shield 226 will moveat the same speed and distance. Alternatively, the first and secondpneumatic or hydraulic cylinders 260, 262 may be of different diameterschosen to provide a predetermined ratio of the speed and distance movedby the first and second moving shields 206, 226.

Using hydraulic cylinders for the connection system will provide moreprecise coordination of the movement of the first and second movingshields 206, 226. On the other hand, using pneumatic cylinders for theconnection system will provide a spring action that will compensatesomewhat for different distances that the first and second movingshields 206, 226 must move depending on the imaging angle and theanatomy of the patient. If pneumatic cylinders are used, it may bedesirable to prepressurize the connection system for a stronger springaction and therefore a more immediate response of the counterbalancingfunction. Movement of the first and second moving shields 206, 226 canbe active, e.g. with a motor or another actuator mechanism, or it may bepassive, e.g. with a light spring that urges the first and second movingshields 206, 226 inward toward the extended position.

FIG. 14 illustrates a fluoroscope C-arm 106 with a radiation protectiondevice 130 wherein the first radiation shield 132 and the secondradiation shield 134 act as counterweights to each other via anotherconfiguration of a pneumatic or hydraulic connection system. The firstand second radiation shields 132, 134 are configured similarly to theexample in FIG. 13. A first pneumatic or hydraulic cylinder 260 isconnected between the first stationary shield 204 and the first movingshield 206. A second pneumatic or hydraulic cylinder 262 is connectedbetween the second stationary shield 224 and the second moving shield226. A first connection tube 280 makes a fluid connection between thecylinder head end 274 of the first pneumatic or hydraulic cylinder 260and a pressure-to-suction converter 284. A second connection tube 282makes a fluid connection between the cylinder head end 268 of the secondpneumatic or hydraulic cylinder 262 and the pressure-to-suctionconverter 284. For this application, the first and second pneumatic orhydraulic cylinders 260, 262 can both be configured as single-actingcylinders.

The pressure-to-suction converter 284 in this example is configured witha third pneumatic or hydraulic cylinder 286 and a fourth pneumatic orhydraulic cylinder 288 arranged parallel to one another. There is amechanical connection 290 between the third pneumatic or hydrauliccylinder 286 and the fourth pneumatic or hydraulic cylinder 288.Similarly, there is a mechanical connection 296 between the rod 292 ofthe third pneumatic or hydraulic cylinder 286 and the rod 294 of thefourth pneumatic or hydraulic cylinder 288, so that the third and fourthpneumatic or hydraulic cylinders 286, 288 will extend and retract inunison. The first connection tube 280 makes a fluid connection with thecylinder head end of the third pneumatic or hydraulic cylinder 286 andthe second connection tube 282 makes a fluid connection with thecylinder head end of the fourth pneumatic or hydraulic cylinder 288. Theresult of this configuration is that pressure in the cylinder head end274 of the first pneumatic or hydraulic cylinder 260 due to the weightof the first moving shield 206 will be transmitted through the firstconnection tube 280 to the pressure-to-suction converter 284; then thepressure-to-suction converter 284 converts the pressure into suction (ornegative pressure) and transmits this suction through the secondconnection tube 282 to the cylinder head end 268 of the second pneumaticor hydraulic cylinder 262, which lifts the second moving shield 226.Thus, the first and second radiation shields 132, 134 will extend andretract in unison, with the weight of the first moving shield 206 andthe weight of the second moving shield 226 counterbalancing each other.

Movement of the first and second moving shields 206, 226 can be active,e.g. with a motor or another actuator mechanism, or it may be passive,e.g. with a light spring that urges the first and second moving shields206, 226 inward toward the extended position. Another option would be toutilize the pneumatic or hydraulic connection system as part of anactuator mechanism for actively extending and retracting the first andsecond radiation shields 132 134. For example, a motor or linearactuator 298 could be used for moving the rods 292, 294 of the third andfourth pneumatic or hydraulic cylinders 286, 288 to actively extend andretract the first and second radiation shields 132 134 in unison, withthe weight of the first moving shield 206 and the weight of the secondmoving shield 226 counterbalancing each other through the pneumatic orhydraulic connection system.

As in the previous example, using hydraulic cylinders for the connectionsystem will provide more precise coordination of the movement of thefirst and second moving shields 206, 226, but using pneumatic cylindersfor the connection system will provide a spring action that willcompensate somewhat for different distances that the first and secondmoving shields 206, 226 must move depending on the imaging angle and theanatomy of the patient. If pneumatic cylinders are used, it may bedesirable to prepressurize the connection system for a stronger springaction and therefore a more immediate response of the counterbalancingfunction.

Although the counterweight systems described above are shown used withtelescoping radiation shields, the counterweight systems may also beused with other configurations of radiation shields, such as flexiblebellows-shaped radiation shields.

FIGS. 15-16 are cross section views of an articulated conical radiationshield 300 that can be used for the first and/or second radiationshields 132, 134 in various embodiments of the radiation protectiondevice 130 described herein. The articulated conical radiation shield300 is constructed with multiple telescoping elements 302, 304, 306,308, 310. The outermost telescoping element 310 is connected to theX-ray source 102 or the image intensifier 104. Each of the intermediatetelescoping elements 304, 306, 308 is configured with an approximatelycylindrical or conical wall 312 with a flange 314 on the inner end thatextends radially outward and a flange 316 on the outer end that extendsradially inward. The outermost telescoping element 310 need only includethe cylindrical or conical wall 312 and the flange 314 on the inner endthat extends radially outward, whereas the innermost telescoping element302 need only include the cylindrical or conical wall 312 and the flange316 on the outer end that extends radially inward. A flexible and/orinflatable conforming pad 142 is mounted around the opening on the innerend of the innermost telescoping element 302. (Note that thedesignations of “outer” and “inner” are given with respect to the centerof the C-arm 106 where the patient is positioned.)

The telescoping elements 302, 304, 306, 308, 310, which may vary innumber, are stacked together in a telescoping manner, as shown in FIG.15. Each of the telescoping elements 302, 304, 306, 308, 310 isprogressively smaller in diameter moving from the innermost telescopingelement 302 to the outermost telescoping element 310, giving an overallconical configuration to the radiation shield 300. The telescopingelements 302, 304, 306, 308, 310 allow the radiation shield 300 toextend and retract and angulate. Optionally, detents 318 may be providedon the outside surface of the telescoping elements 302, 304, 306, 308,310 near the outer edge of the cylindrical or conical wall 312 toprevent the stack of elements from retracting too far and becomingdisconnected.

FIG. 15 shows the articulated conical radiation shield 300 in a fullyextended position and FIG. 16 shows the articulated conical radiationshield 300 in an angled position. In all positions of the radiationshield 300, the overlapping flanges 314, 316 create a baffle thatprevents X-rays from escaping though the sliding gaps between thetelescoping elements 302, 304, 306, 308, 310.

FIGS. 17-18 are cross section views of an articulated cylindricalradiation shield 320 that can be used for the first and/or secondradiation shields 132, 134 in various embodiments of the radiationprotection device 130 described herein. The articulated cylindricalradiation shield 320 is constructed with multiple telescoping elements322, 324, 326, 328, 330, 332, 334. The outermost telescoping element 334is connected to the X-ray source 102 or the image intensifier 104. Themultiple telescoping elements are of two general types: inside ringtelescoping elements 322, 326, 330, 334 and outside ring telescopingelements 324, 328, 332. Each of the intermediate inside ring telescopingelements 326, 330 is configured with an approximately cylindrical wall336 with a flange 338 on the inner end that extends radially outward anda flange 340 on the outer end that extends radially outward. Theoutermost inside ring telescoping element 322 need only include thecylindrical wall 336 and the flange 340 on the inner end that extendsradially outward, whereas the innermost inside ring telescoping element334 need only include the cylindrical wall 336 and the flange 338 on theouter end that extends radially outward. Each of the outside ringtelescoping elements 324, 328, 332 is configured with an approximatelycylindrical wall 342 with a flange 344 on the inner end that extendsradially inward and a flange 346 on the outer end that extends radiallyinward.

The telescoping elements 322, 324, 326, 328, 330, 332, 334, which mayvary in number, are stacked together in an interlocking and telescopingmanner, giving an overall cylindrical configuration to the radiationshield 320, as shown in FIG. 17. The outside ring telescoping elements324, 328, 332 are preferably configured as split rings to facilitateassembly of the radiation shield 320. A flexible and/or inflatableconforming pad 142 is mounted around the opening on the inner end of theinnermost telescoping element, which in the example shown is an insidering telescoping element 334. The telescoping elements 322, 324, 326,328, 330, 332, 334 allow the radiation shield 320 to extend and retractand angulate.

FIG. 17 shows the articulated cylindrical radiation shield 320 in afully extended position, and FIG. 18 shows the articulated cylindricalradiation shield 320 in an angled position. In all positions of theradiation shield 320, the overlapping flanges 338, 340, 344, 346 createa baffle that prevents X-rays from escaping though the sliding gapsbetween the telescoping elements 322, 324, 326, 328, 330, 332, 334.

FIG. 19 illustrates an articulated conical radiation shield 350 withtelescoping dome-shaped shield elements 352, 354, 356, 358. Thisembodiment is a variation of the articulated conical radiation shield300 shown in FIGS. 15-16 and is quite similar in construction. Each ofthe intermediate telescoping elements 354, 356 is configured with a sidewall 360 with a flange 362 on the inner end that extends radiallyoutward and a flange 364 on the outer end that extends radially inward.The side walls 360 have a tapering dome-shaped geometry with a curvaturechosen to minimize the gap between adjacent shield elements when theradiation shield 350 is in an angulated position. Looking at shieldelement 354 as an example, the side wall 360 tapers down in diameterfrom the inner edge to the outer edge of the side wall 360 with acurvature that can be defined as a surface of rotation made by an arcwith a radius r.sub.1 equal to the diameter of the shield element 354 atthe junction of the side wall 360 and the flange 362 with the center ofthe arc located at the junction of the side wall 360 and the flange 362rotated about the center line 240 of the shield element 354. The sidewalls 360 of shield elements 356, 358 have similar geometries defined asa surface of rotation made by an arc with a radius r.sub.2, and r.sub.3respectively rotated about the center line 240 of the shield elements356, 358. This geometry assures that any gap between the shield elements352, 354, 356, 358 will remain relatively constant when the radiationshield 350 is in an angulated position. This will enhance theeffectiveness of the overlapping flanges 362, 364 to create a bafflethat prevents X-rays from escaping though the sliding gaps between thetelescoping shield elements 352, 354, 356, 358.

FIG. 20 illustrates an articulated conical radiation shield 300, similarto the one shown in FIGS. 15-16, with an actuation system 370 usinglinear actuators 372, 374 for extending, retracting and angulating theradiation shield 300. The actuation system 370 can also be used withvarious other embodiments of radiation shields described herein. FIG. 20shows one pair of cooperating linear actuators, including a first linearactuator 372 and a second linear actuator 374 arranged on opposite sidesof the radiation shield 300 and connected between the innermost shieldelement 302 and the outermost shield element 310. Preferably, theactuation system 370 is configured with three or four such linearactuators arranged around the periphery of the radiation shield 300 toprovide angulation in all directions. The linear actuators 372, 374 canbe hydraulic or pneumatic cylinders, linear motors, motorized leadscrews, rack-and-pinion mechanisms, scissors mechanisms,cable-and-pulley mechanisms, solenoids or any other known linearactuator mechanism. The radiation shield 300 is retracted away from thepatient by retracting all of the linear actuators 372, 374. Conversely,the radiation shield 300 is extended toward the patient by extending allof the linear actuators 372, 374. To angulate the radiation shield 300,one of the linear actuators 372 is retracted and the other one of thelinear actuators 374 is extended, as shown in FIG. 20. The actuationsystem 370 uses different combinations of extension, retraction andangulation to position the radiation shield 300 between the X-ray source102 or the image intensifier 104 and the patient for differentfluoroscopic views.

Another optional configuration of the actuation system 370 could usemultiple smaller linear actuators connected between each pair ofadjacent shield elements 302, 304, 306, 308, 310 of the radiation shield300. The cumulative action of the multiple smaller linear actuators willbe equivalent to the three or four large linear actuators in the exampledescribed above.

FIG. 21 illustrates a fluoroscope C-arm 106 with a radiation protectiondevice 380 positioned for an oblique fluoroscopic view. The radiationprotection device 380 in this example has a cylindrical first stationaryshield 382 attached to the X-ray source 102 with a conical first movingshield 384 slidably mounted on it and a cylindrical second stationaryshield 386 attached to the image intensifier 104 with a conical secondmoving shield 388 slidably mounted on it. Optionally, overlappingflanges or other means described herein can be used to prevent X-raysfrom escaping through any gaps between the moving shields 386, 388 andthe stationary shields 382, 384. A first flexible and/or inflatableconforming pad 142 is mounted around the opening on the inner end of thefirst moving shield 384 and a second flexible and/or inflatableconforming pad 144 is mounted around the opening on the inner end of thesecond moving shield 388. The first moving shield 384 and the secondmoving shield 388 are shown in retracted positions. FIG. 21 alsoillustrates an optional feature that may be used with variousembodiments of radiation shields described herein. One or more distancesensors 390, 392, 394, 396 may be used to measure the distance betweenthe X-ray source 102 and/or the image intensifier 104 and the patient Pfor extending the moving shields 386, 388 the correct distance. Ifmultiple distance sensors 390, 392, 394, 396 are used, the properangulation for the moving shields 386, 388 can also be determined. Thedistance sensors 390, 392, 394, 396 may be ultrasonic or laser baseddistance sensors or other known distance sensors. Alternatively,scanning distance sensors can be used to measure the distance andprofile of the patient for determining the correct extension length andangulation for the moving shields 386, 388. The distance sensors 390,392, 394, 396 may be mounted on the X-ray source 102 and the imageintensifier 104 or other fixed position relative to the C-arm 106.Alternatively, distance sensors 390′, 392′, 394′, 396′ may be mounted onthe moving shields 386, 388. In this case, the distance sensors 390′,392′, 394′, 396′ can be used initially to measure the distance and angleto extend the moving shields 386, 388. Then, as the moving shields 386,388 approach the patient P, the distance sensors 390′, 392′, 394′, 396′can serve as proximity sensors to determine when to stop extending themoving shields 386, 388 and inflate or extend the first and secondconforming pads 142, 144.

FIG. 22 illustrates a fluoroscope C-arm 106 with the radiationprotection device 380 of FIG. 21 with the conical first and secondmoving shields 386, 388 shown in an extended position and angulated toapproximate the local surface profile of the patient P. The first andsecond conforming pads 142, 144 have been inflated to close any gapsbetween the moving shields 386, 388 and the surface of the patient P.Inflation of the conforming pads 142, 144 can be sequenced with theextension of the moving shields 386, 388 or, alternatively, theconforming pads 142, 144 can be always inflated to a low pressure sothat they will passively conform to the surface of the patient P.

The radiation protection device 380 may utilize an actuation system 370,such as the one shown in FIG. 20, for movement of the first and secondmoving shields 386, 388. In addition, the radiation protection device380 may utilize counterweights or self-counterbalancing to reduce theforces needed to extend and retract the first and second moving shields386, 388.

FIG. 23 illustrates a fluoroscope C-arm 106 with a radiation protectiondevice 400 with articulated conical radiation shields 402, 404, similarto the ones shown in FIG. 15-16 or 19. The articulated conical radiationshields 402, 404 are shown in a fully retracted position. Optionally,distance sensors 390, 392, 394, 396 may be used to determine thedistance and proper angulation for extending the radiation shields 402,404.

FIG. 24 illustrates a fluoroscope C-arm 106 with the radiationprotection device 400 of FIG. 23 with the articulated conical radiationshields 402, 404 shown in an extended position and angulated toapproximate the local surface profile of the patient P. The first andsecond conforming pads 142, 144 have been inflated to close any gapsbetween the radiation shields 402, 404 and the surface of the patient P.Inflation of the conforming pads 142, 144 can be sequenced with theextension of the radiation shields 402, 404 or, alternatively, theconforming pads 142, 144 can be always inflated to a low pressure sothat they will passively conform to the surface of the patient P.

The radiation protection device 400 may utilize an actuation system 370,such as the one shown in FIG. 20, for movement of the first and secondarticulated conical radiation shields 402, 404. In addition, theradiation protection device 400 may utilize counterweights orself-counterbalancing to reduce the forces needed to extend and retractthe first and second radiation shields 402, 404.

Alternatively or in addition to the distance sensors and proximitysensors described above, the radiation protection device of the resentinvention may include a controller that calculates or estimates theproper distance and/or angulation for extending the first and/or secondradiation shields based on the position and angle of the desiredfluoroscopic view and the anatomic profile of the patient's body. Thecontroller may utilize an electronically implemented algorithm and/orlook-up tables to determine the distance and/or angulation for extendingthe first and/or second radiation shields. This can be implemented bythe controller using hardware, software and/or firmware. This featurecan be incorporated into an automated version of the radiationprotection device, allowing the radiation shields to quickly move to thecorrect positions for maximal protection of the operator and thepatient. The angle and position of the C-arm for the calculation may bemeasured directly or it may be based on a control command entered by theoperator for selection of the C-arm angle and position.

While the radiation protection device has been described for use withC-arm fluoroscopy equipment, the invention can also be used with otherimaging and treatment modalities requiring radiation protection. Forexample, some biplane fluoroscopy imaging systems are configured with anentire circle that supports two X-ray sources and two imageintensifiers, rather than a C-arm per se. Other fluoroscopy imagingsystems are configured with the X-ray source floor-mounted below theexamination table and the image intensifier ceiling-mounted orcantilevered over the patient. The radiation protection device of thepresent invention can be equally well adapted to these imaging systems,as well as many imaging and treatment systems with other geometries.

Any one of the embodiments of the radiation protection device describedherein may also be configured to include a grid, known as a Bucky gridor Bucky-Potter grid, between the patient and the image intensifier toreduce the blurring effect of scattered radiation on the imaging device.An extra long grid may be beneficial to eliminate any scatteredradiation that might be caused by the radiation protection deviceitself.

Since the radiation protection devices of the present invention will addextra weight to the C-arm of the fluoroscope, it may be necessary toreinforce the supporting structures of the C-arm and/or to add ballastor a wider base to the supporting structures to prevent the extra weightfrom destabilizing the C-arm.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

What is claimed is:
 1. A radiation protection device for an x-ray sourceand an x-ray imaging device, the radiation protection device comprising:a first radiation shield having a first end and a second end, the firstend of the first radiation shield positioned around the x-ray source,the second end of the first radiation shield being adapted to contact abody of a patient; a second radiation shield having a first end and asecond end, the first end of the second radiation shield positionedaround the x-ray imaging device, the second end of the second radiationshield being adaptable to contact the body of the patient at a locationwhich receives x-rays from the x-ray source; a first soft, conformableedge surrounding the second end of the first radiation shield forcontacting a surface of the body of the patient; and a second soft,conformable edge surrounding the second end of the second radiationshield for contacting a surface of the body of the patient.